A Cut-off Value Study of N-terminal Brain Natriuretic Peptide （Chemiluminescence Method）

NCT06691477 | Completed

• 1 other identifier: CHN-199
• Study Type: observational
• Target: 1,104
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of the study is to evaluate diagnostic performance of N-terminal Brain natriuretic Peptide (NT-proBNP) in acute heart failure among Chinese population. Further, it sought to explore the optimal cut-off point fitting Chinese patients.

Conditions

Heart Failure; Acute Coronary Syndromes

Keywords

NT-proBNP; Natriuretic Peptides; Diagnosis; acute heart failure; biomarker

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy: Sensitivity and specificity

  This study aims to evaluate the diagnostic performance of NT-proBNP for acute HF in patients with dyspnea in emergency department setting.

  Baseline

Study Arms (2)

Heart Failure Cohort

Other: No Interventions

Non-Heart Failure Cohort with suspected HF syndrome

Other: No Interventions

Interventions

No Interventions OTHER

No intervention required. Subjects accepted regular medical treatment

Heart Failure Cohort; Non-Heart Failure Cohort with suspected HF syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Plan to 1060 Chinese patients presenting to emergency department with acute dyspnea in 3 hospitals, 2 of which are in Guangzhou and 1 in Beijing.

You may qualify if:

• Age: ≥ 18 years old to voluntarily participate in this study and sign the informed consent form.
• Subjects Remaining serum or plasma sample size \> 500 ml.
• Have symptoms that would make the investigator suspect that they are related to heart failure.
• Dyspneic patients presenting to 3 EDs in China were enrolled and had sufficient blood for subsequent NT-proBNP measurement.

You may not qualify if:

• Chronic kidney disease stage 4 or 5.
• Chronic renal dialysis.
• Participation in clinical studies that may interfere with participation in this study;
• Any behavior that would increase the subject's risk or prevent the subject from fully complying with or completing this study;
• The sample size is not enough for testing;
• Hemolysis, lipidemia or jaundice may be visible to the naked eye in the sample.

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (4)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangzhou, 510000, China

Location

Beckman Coulter

Shanghai, Shanghai Municipality, 200335, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

The Second Affiliated Hospital of Gungzhou Medical University

Guangzhou, 510000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Remaining serum or plasma, sample volume\> 500 μl

MeSH Terms

Conditions

Heart Failure; Acute Coronary Syndrome; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: April 10, 2023
• Primary Completion: September 18, 2024
• Study Completion: October 11, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (4)